Local Anesthesia Before Arterial Puncture for Blood Gas Analysis (GAEL)

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Indication of Blood Gas Analysis by Radial Artery Blood Sampling

Treatments: Drug: Placebo; Drug: lidocaïne/prilocaïne 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT01964248

RB 12.011 (GAEL)

Details and patient eligibility

About

The aim of the study is to evaluate the interest of Local Anesthesia (lidocaïne/prilocaïne versus placebo)before arterial puncture for Blood Gas Analysis. The pain is measured with a numeric Pain Intensity for all patients included.

Full description

In an approach of continuous improvement of the quality of the care, this project joins logically after a reflection on the treatment of pain generated by the care in the department of Pneumology 1 / septic Thoracic and vascular Cardiac Surgery.

The arterial puncture for blood gas analysis is an act with aim diagnosis which allows to study gases of the arterial blood to watch the hematosis of the patient. This act appears at the top of the anticipated care as painful by the nursing teams.

In the literature, we find no study carried out with the eutectic mixture lidocaïne prilocaïne. Other local anesthetics and other local ways of administration were estimated and the results diverge as for the efficiency of a local anesthetic for the arterial blood sample at the level radial nerve. Finally authors showed a correlation between certain factors(mailmen) and the painful character of the arterial blood sample, without defining really of population.

In this context, it is necessary to estimate the interest of a local anesthetic before arterial sampling of blood by a study randomized in insu double and versus placebo.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged more than 18 years old, having signed an enlightened consent, who have an indication of gazometry by taking radial nerve
• Patients capable of estimating the pain felt with numeric pain intensity scale
• Patients with numeric pain intensity scale = 0 before sample of blood
• Patients with no contraindication or no allergy of an anesthetic such as lidocaine

Exclusion criteria

• Patients aged less than 18 years old
• Patients incapable of estimating the pain felt with numeric pain intensity scale
• Patients with numeric pain intensity scale > 0 before sample of blood
• Patients for whom the arterial taking is impossible for the level radial nerve
• Hypersensibility to local anesthetics of the amide-type or other component of lidocaïne/prilocaïne cream
• Porphyries known
• Pregnant woman

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

136 participants in 2 patient groups, including a placebo group

Lidocaïne/prilocaïne

Experimental group

Description:

* Lidocaine/prilocaine eutectic mixture 5% incorporated in a cream base * Single dose: 2 grams (one tube of cream) * Cream applied 2 hours before blood sample

Treatment:

Drug: lidocaïne/prilocaïne 5%

Placebo

Placebo Comparator group

Description:

* Single dose: 2 grams (one tube of cream) * Cream applied 2 hours before blood sample

Treatment:

Drug: Placebo